NORADRENALINE (NOREPINEPHRINE) 1 mg / ml Concentrate for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Noradrenaline (Norepinephrine) is and what it is used for
2. What you need to know before you are given Noradrenaline (Norepinephrine)
3. How you are given Noradrenaline (Norepinephrine)
4. Possible side effects
5. How to store Noradrenaline (Norepinephrine)
6. Contents of the pack and other information

• if you are allergic to noradrenaline (norepinephrine) or to any of the other ingredients of this medicine (listed in section 6);
• if you are hypotensive (have low blood pressure) that has been caused by hypovolaemia (low blood volume);
• if you are taking some anaesthetics such as halothane or cyclopropane (this may increase the risk of irregular heart beat).

Talk to your doctor, pharmacist or nurse before you are given Noradrenaline (Norepinephrine) if you:

• have major left ventricular dysfunction (a heart condition);
• have coronary (blood clot inside a blood vessel of the heart), mesenteric (blood clot in a vein that drains blood from the intestine), or peripheral vascular thrombosis (blood clot in the vein of arm or leg);
• have hypotension (low blood pressure) following myocardial infarction (heart attack);
• have Prinzmetal’s variant angina;
• have heart rhythm disorders during your treatment – you will need a reduced dose;
• have hyperthyroidism (thyroid gland problem);
• have diabetes mellitus;
• are elderly.

Additional monitoring tests that you may be required to undergo during treatment:

Your blood pressure and heart rate will be checked frequently during your treatment to avoid hypertension (high blood pressure).

The safety and efficacy of norepinephrine in children less than 18 years of age has not been established. Therefore, use in children is not recommended.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The following medicines may influence the effect of Noradrenaline (Norepinephrine):

• Halothane, cyclopropane, chloroform, enflurane or other halogenated anaesthetics are contraindicated (see section 2 of this leaflet, subsection “you must not be given”): these medicines are anaesthetics, they cause insensibility to pain and are used before some operations. If you are taking these medicines as well as noradrenaline (norepinephrine) this may increase the risk of irregular heart beat.
• Amitriptiline, imipramine, trimipramine, moclobemide, iproniazide, phenelzine, fluoxetine, sertraline, desipramine: these medicines are used for treatment of depression. Taking any of these medicines together with noradrenaline (norepinephrine) can dangerously increase its concentration in the blood and therefore its pressor action.
• Digitalis glycosides may occasionally cause irregular heart beat.
• Levodopa may enhance the effects of noradrenaline (norepinephrine).
• Antihistamines, as some may block the intake of catecholamines by peripheral tissues and increase the toxicity of injected noradrenaline (norepinephrine).
• Chlorpheniramine hydrochloride, tripelennamine hydrochloride: significantly increase the toxicity of noradrenaline (norepinephrine).
• Non-selective MAO inhibitors (or within 14 days of cessation of such therapy): increase in the pressor action of the sympathomimetic which is usually moderate. Should only be used under close medical supervision.
• Selective MAO-A inhibitors: by extrapolation from non-selective MAO inhibitors, risk of increase in the pressor action. Should only be used under close medical supervision.
• Linezolid, an antibiotic (medicine used to treat infections caused by bacteria and other microorganisms), can dangerously increase noradrenaline (norepinephrine) concentration in the blood and therefore its pressor action, when taken together.
• Alpha and beta-blockers: if you are taking these medicines as well as noradrenaline (norepinephrine) this may increase the risk of severe hypertension (high blood pressure).
• Thyroid hormones, cardiac (heart) glycosides, anti-arrhythmics: if you are taking these medicines as well as noradrenaline (norepinephrine) this may cause increased cardiac (heart) effects.
• Ergot alkaloids or oxytocin may enhance the vasopressor and vasoconstrictive (increasing blood pressure) effects.
• Desmopressin or vasopressin: its antidiuretic effect is diminished.
• Lithium decreases the effect of noradrenaline (norepinephrine).
• Guanethidine, guanadrel, reserpine, methyldopa or tricyclic antidepressants, amphetamine, doxapram, mazindol, rauwolfia alkaloids: may enhance the effects of noradrenaline (norepinephrine).
• Propofol: Concomitant administration may lead to propofol infusion syndrome (PRIS).

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before this medicine is given to you. Noradrenaline may harm the unborn baby. Your doctor will decide if you should be given Noradrenaline.

It is not known whether this medicine is excreted in human milk. Because many medicines are excreted in human milk, caution should be exercised when norepinephrine is given to a nursing woman.

Since this medicine will be given to you in a hospital, your doctor will inform you when you will be able to drive or use machines.

This medicine contains 3.3 mg sodium (main component of cooking/ table salt) in each ml. This is equivalent to 0.16 % of the recommended maximum daily dietary intake of sodium for an adult.

Noradrenaline (Norepinephrine) is first diluted and then infused into a vein. It should not be mixed with other medicines. The dose of noradrenaline (norepinephrine) depends on the condition of the patient. Your doctor will know the best dose to use. The initial dose is 0.4 to 0.8 mg per hour of noradrenaline (norepinephrine) (equivalent to 0.8 to 1.6 mg per hour of noradrenaline (norepinephrine) tartrate). The dose can then be adjusted using a pump according to the response to treatment, with the aim to establish a normal blood pressure. Your doctor will monitor your blood pressure and blood volume.

It is unlikely that you will receive too much as this medicine will be given to you in hospital. However, talk to your doctor or nurse if you have any concerns.

Symptoms that may occur if you are given too much noradrenaline (norepinephrine) are severe high blood pressure, slow heartbeat, violent headache, light sensitivity, pain in the chest, bleeding in the brain, pallor, fever, intense sweating and vomiting, fluid in the lungs causing breathlessness.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is noradrenaline (norepinephrine).

Each ml of concentrate for solution for infusion contains 2 mg noradrenaline (norepinephrine) tartrate, equivalent to 1 mg noradrenaline (norepinephrine).

Each ampoule of 4 ml contains 8 mg noradrenaline (norepinephrine) tartrate, equivalent to 4 mg noradrenaline (norepinephrine).

Each ampoule of 8 ml contains 16 mg noradrenaline (norepinephrine) tartrate, equivalent to 8 mg noradrenaline (norepinephrine).

The other ingredients are sodium chloride, sodium hydroxide or hydrochloric acid and water for injections.

Clear, colourless or slightly yellowish solution of pH 3.0 to 4.0 packaged in a clear glass ampoule of 4 ml or 8 ml.

Boxes of 10, 50 or 100 ampoules.

Not all pack sizes may be marketed.